[Federal Register Volume 78, Number 95 (Thursday, May 16, 2013)]
[Proposed Rules]
[Pages 29016-29017]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11551]
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NUCLEAR REGULATORY COMMISSION
10 CFR Part 71
[NRC-2013-0082; NRC-2008-0198]
RIN 3150-AI11
Establishing Quality Assurance Programs for Packaging Used in
Transport of Radioactive Material
AGENCY: Nuclear Regulatory Commission.
ACTION: Draft regulatory guide; request for comment.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is proposing to
amend its regulations for the packaging and transportation of
radioactive material. The NRC is issuing for public comment draft
regulatory guide (DG), DG-7009, ``Establishing Quality Assurance
Programs for Packaging Used in Transport of Radioactive Material.''
This draft regulatory guide describes a proposed method that the NRC
staff considers acceptable for use in complying with the NRC's proposed
amendments to its regulations on quality assurance programs related to
transport of radioactive materials.
DATES: Submit comments by July 30, 2013. Comments received after this
date will be considered if it is practical to do so, but the NRC is
able to ensure consideration only for comments received on or before
this date. Although a time limit is given, comments and suggestions in
connection with items for inclusion in guides currently being developed
or improvements in all published guides are encouraged at any time.
ADDRESSES: You may submit comments by any of the following methods
(unless this document describes a different method for submitting
comments on a specific subject):
Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2013-0082. Address
questions about NRC dockets to Carol Gallagher; telephone: 301-492-
3668; email: Carol.Gallagher@nrc.gov. For technical questions, contact
the individuals listed in the FOR FURTHER INFORMATION CONTACT section
of this document.
Mail comments to: Cindy Bladey, Chief, Rules,
Announcements, and Directives Branch (RADB), Office of Administration,
Mail Stop: TWB-05-B01M, U.S. Nuclear Regulatory Commission, Washington,
DC 20555-0001.
Fax comments to: RADB at 301-492-3446.
For additional direction on accessing information and submitting
comments, see ``Accessing Information and Submitting Comments'' in the
SUPPLEMENTARY INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT: Jessica Glenny, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001; telephone: 301-492-
3285, email: Jessica.Glenny@nrc.gov.
SUPPLEMENTARY INFORMATION:
I. Accessing Information and Submitting Comments
A. Accessing Information
Please refer to Docket ID NRC-2013-0082 when contacting the NRC
about the availability of information regarding this document. You may
access information related to this document, which the NRC possesses
and is publicly available, by the following methods:
Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2013-0082.
NRC's Agencywide Documents Access and Management System
(ADAMS): You may access publicly available documents online in the NRC
Library at http://www.nrc.gov/reading-rm/adams.html. To begin the
search, select ``ADAMS Public Documents'' and then select ``Begin Web-
based ADAMS Search.'' For problems with ADAMS, please contact the NRC's
Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-
4737, or by email to pdr.resource.gov@nrc.gov">pdr.resource.gov@nrc.gov. The draft regulatory
guide is available in ADAMS under Accession No. ML13079A004. The draft
regulatory analysis for the proposed rule may be found in ADAMS under
Accession No. ML13079A005. Because this draft regulatory analysis
explains the reasons for revising the rule and its implementing
guidance, a separate regulatory analysis was not prepared for this
draft regulatory guide.
NRC's PDR: You may examine and purchase copies of public
documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555
Rockville Pike, Rockville, Maryland 20852.
Regulatory guides are not copyrighted, and NRC approval is not
required to reproduce them.
B. Submitting Comments
Please include Docket ID NRC-2013-0082 in the subject line of your
comment submission, in order to ensure that the NRC is able to make
your comment submission available to the public in this docket.
The NRC cautions you not to include identifying or contact
information that you do not want to be publicly disclosed in you
comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into
ADAMS. The NRC does not routinely edit comment submissions to remove
identifying or contact information.
If you are requesting or aggregating comments from other persons
for submission to the NRC, then you should inform those persons not to
include identifying or contact information that they do not want to be
publicly disclosed in their comment submission.
[[Page 29017]]
Your request should state that the NRC does not routinely edit comment
submissions to remove such information before making the comment
submissions available to the public or entering the comment submissions
into ADAMS.
II. Proposed Rule
In the Proposed Rules section of this issue of the Federal
Register, the NRC published a proposed rule, ``Revisions to
Transportation Safety Requirements and Harmonization with International
Atomic Energy Agency Transportation Requirements'' (RIN 3150-AI11; NRC-
2008-0198), that would amend its regulations for the packaging and
transportation of radioactive material in Part 71 of Title 10 of the
Code of Federal Regulations (10 CFR). These amendments would make the
NRC's regulations compatible with the 2009 edition of the International
Atomic Energy Agency's (IAEA) transportation standards, ``Regulations
for the Safe Transport of Radioactive Material'' (TS-R-1); maintain
consistency with changes in the U.S. Department of Transportation's
regulations; and make other changes to the requirements for the
packaging and transportation of radioactive material.
III. Draft Regulatory Guide
The NRC is issuing for public comment a draft regulatory guide in
the NRC's ``Regulatory Guide'' series. This series was developed to
describe and make available to the public such information as methods
that are acceptable to the NRC staff for implementing specific parts of
the NRC's regulations, techniques that the staff uses in evaluating
specific problems or postulated accidents, and data that the staff
needs in its review of applications for permits and licenses.
In conjunction with the proposed rule, the NRC is issuing DG-7009,
``Establishing Quality Assurance Programs for Packaging Used in
Transport of Radioactive Material.'' The draft regulatory guide is
temporarily identified by its task number, DG-7009. The DG-7009 is
proposed Revision 3 of Regulatory Guide 7.10, with the same title,
dated March 2005, available in ADAMS under Accession No. ML050540330.
This draft regulatory guide describes a proposed method that the
NRC staff considers acceptable for use in complying with the NRC's
proposed regulations on quality assurance (QA) programs related to
transport of radioactive materials.
This draft regulatory guide is being revised to address changes to
the regulation of QA programs issued under 10 CFR part 71. These
changes include: (1) establishing requirements to allow some changes to
be made to a previously approved QA program without obtaining NRC
approval, and (2) removing the requirements for renewal of QA program
approvals.
If adopted in final form, DG-7009 would supersede Regulatory Guide
7.10, Revision 2, and would represent the NRC staff's guidance for
future users, including licensees, certificate holders, and applicants.
IV. Backfitting and Issue Finality
This draft regulatory guide contains proposed NRC guidance on one
acceptable means of addressing NRC requirements in 10 CFR part 71 on QA
programs related to transport of radioactive materials. The NRC
proposes to determine that the draft regulatory guide may be adopted in
final form without preparation of a backfit analysis or further
documentation of backfitting and issue finality. There are two bases
for the NRC's proposed determination, which are addressed separately in
the following paragraphs.
Lack of Backfitting or Issue Finality Provisions Applicable to Entities
With Respect to Requirements in 10 CFR Part 71
Part 71 of 10 CFR does not contain any backfitting or issue
finality provisions protecting persons and entities subject to its
provisions. The NRC recognizes that persons and entities required to
comply with the 10 CFR Part 71 QA requirements, such as nuclear power
plant licensees, may also be protected by backfitting and issue
finality protection under other parts of 10 CFR Chapter I. Nonetheless,
it is the NRC's position that those backfitting and issue finality
protections are limited to activities directly regulated under those
parts, and do not apply to activities regulated under other parts
without backfitting or issue finality protections. The exception to
this general principle is where the activity regulated under other
parts without backfitting or issue finality protections is an
inextricable part of the regulated activity subject to backfitting or
issue finality.
However, the exception to this principle is not applicable to the
issuance of this regulatory guide, which addresses QA for
transportation of radioactive materials. Nuclear power plant licensees,
for example, are protected by backfitting requirements in 10 CFR
50.109, and (depending upon the circumstance) issue finality
requirements in 10 CFR part 52. Nonetheless, quality assurance
governing transportation of certain radioactive materials is not an
inextricable part of the licensed activity in 10 CFR parts 50 and 52,
viz. the design, construction and operation of a nuclear power plant.
Analogous arguments also apply with respect to entities protected by
backfitting requirements in 10 CFR parts 70, 72, and 76.
First Issuance of Guidance on a New or Amended Regulation
This draft regulatory guide addresses proposed changes to the
regulation of QA programs issued under 10 CFR Part 71, which are being
published in a companion notice in this issue of the Federal Register.
These changes include: (1) establishing requirements to allow some
changes to be made to a previously approved QA program without
obtaining NRC approval, and (2) removing the requirements for renewal
of QA program approvals. The first issuance of guidance on a newly-
changed or newly-added rule provision does not constitute backfitting
or raise issue finality concerns, inasmuch as the guidance must be
consistent with the regulatory requirements in the newly-changed or
newly-added rule provisions and the backfitting and issue finality
considerations applicable to the newly-changed or newly-added rule
provisions must logically apply to this guidance. Therefore, issuance
of guidance addressing the newly-changed and newly-added provisions of
the amended rule does not constitute issuance of ``changed'' or ``new''
guidance within the meaning of the definition of ``backfitting'' in 10
CFR 50.109(a)(1). Similarly, the issuance of the guidance addressing
the newly-changed or newly-added provisions of the amended rule, by
itself, does not constitute an action inconsistent with any of the
issue finality provisions in 10 CFR part 52.
Accordingly, no further consideration of backfitting or issue
finality is needed in order to issue this draft regulatory guide in
final form.
Dated at Rockville, Maryland, this 30th day of April, 2013.
For the Nuclear Regulatory Commission.
Thomas H. Boyce,
Chief, Regulatory Guide Development Branch, Division of Engineering,
Office of Nuclear Regulatory Research.
[FR Doc. 2013-11551 Filed 5-15-13; 8:45 am]
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